A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- MeMed Diagnostics Ltd.
- Enrollment
- 2000
- Locations
- 8
- Primary Endpoint
- Primary objective
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
The study is a multi-center, prospective, observational clinical study enrolling patients from at least 3 medical centers. Study population will include patients over the age of 18 years.
The study will recruit patients presenting with suspicion of acute infection/sepsis and healthy individuals.
Study main objective is to derive and verify a host response based score to predicte severe outcome.
Detailed Description
For determining disease severity each enrolled patient will be assigned as either "severe outcome patient" or "non severe outcome patient" according to predefined criteria. (or "healthy"). Participation in the study requires the collection of routine patient data and blood sample. Blood samples will be used for measurements of host biomarkers that predict disease severity. The blood samples will be collected upon enrollment. In addition, a standardized patient questionnaire inquiring about severity outcomes met up to 28 days after presentation will be conducted by phone call 28 to 42 days post admission. Enrolled patients will be managed according to the current standard of care per standard institutional procedures. Results of the measured biomarkers will not be revealed to the attending clinician and so will not influence patient management.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Suspected acute infection/sepsis patients
- •Patients fulfilling the following criteria are not eligible for inclusion in this study:
- •HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records).
- •Pregnancy- self reported or medically confirmed. Healthy individuals
- •Patients fulfilling the following criteria are not eligible for inclusion in this study:
- •Episode of infection in the last 2 weeks
- •Major trauma and\\or burns and\\or surgery in the last 2 weeks
- •HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records)
- •Elective surgery patients
- •Pregnancy- self reported or medically confirmed
Outcomes
Primary Outcomes
Primary objective
Time Frame: 3,14 and 28 Days
To derive and verify the diagnostic performance of a host-response tool based on novel biomarkers for predicting disease severity in adult patients, aged 18 years or older, presenting with clinical suspicion of acute infection/sepsis.